Clinical Trials Evaluating Proton Therapy

Abstract

Although proton therapy was developed almost 80 years ago, widespread clinical implementation has been limited until the past decade. With the growing use of proton therapy, there is a desire to prove the equivalence or superiority of proton therapy across a number of cancer disease sites. Dozens of clinical trials have been developed to accomplish this within individual institutions, among a few centers, and across national and international networks such as the National Cancer Institute’s National Clinical Trial Network. The protocols include proton therapy imbedded in trials with photon therapy as well as randomized photon vs. proton trials. This chapter provides an overview of the design of such trials as well as some of the challenges facing protocols with proton therapy.

The rationale for a carbon ion radiation therapy facility in Australia

“…However, all discussion recognises that direct high‐level clinical evidence for CIRT benefit is limited, 117 since most clinical CIRT investigations are retrospective single arm studies. This is similar in principle to many PBT applications, although PBT phase III trial numbers are increasing 118–120 . However, many CIRT indications are for rare tumours or those that are inoperable and/or difficult to treat in other ways.…”

“…This is similar in principle to many PBT applications, although PBT phase III trial numbers are increasing. [118][119][120] However, many CIRT indications are for rare tumours or those that are inoperable and/or difficult to treat in other ways. Also, there are not many CIRT centres and the Japanese and European approaches have the differences discussed above.…”